Systemic lupus erythematosus nephritis
Conditions
Interventions
Product Name: Azathioprine
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
University Hospital Gent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria. Each patient must meet all the following inclusion criteria: 1) Newly diagnosed children with untreated and biopsy proven revised WHO Class III, IV proliferative lupus nephritis and 24 hour proteinuria = 500 mg/day. The kidney biopsy specimen will be read by the renal pathologists of the participating centres (light and immunofluorescence) (54). Slides of paraffin-embedded sections from all patients will be re-viewed by a blinded a renal pathologist at the PRINTO coordinating centre. 2) Diagnosis of JSLE according to the ACR revised classification criteria (57); 3) Age at enrolment = 18 years. 4) Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial, and then every 3 months. If sexually active, they must agree to use adequate contraception, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use adequate birth control methods if sexually active. 5) Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate 6) Duly executed, written, informed consent obtained from the parents or other legal representative and/or the patient according to requirement of the local ethics committee. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria. Any of the following will exclude a patient from this trial: 1) Treatment with the CYC, AZA or mycophenolate mofetil anytime before randomisation. 2) Neutrophil count <1,500 cell/mm3 and/or platelet count <50,000/mm3. 3) History of poor compliance with previous treatment. 4) Evidence of current use of alcohol or illicit drugs abuse. 5) Live vaccines not allowed during the entire duration of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness (efficacy, safety, tolerability and compliance to treatment) of 3 CYC regimens for treatment of children with JSLE biopsy proven proliferative lupus glomerulonephritis (revised version of the World Health Organisation WHO class III, IV) ;Secondary Objective: The overall hypothesis to be tested in this JSLE trial is to find out the relative effectiveness of 3 therapeutic schemes, i.e. the lowest effective and safest dose, and the shortest duration of treatment with CYC for the prevention of renal relapses while avoiding gonadal toxicity;Primary end point(s): To assess the effectiveness (efficacy, safety, tolerability and compliance to treatment) of 3 CYC regimens for the treatment of children with JSLE biopsy proven proliferative lupus glomerulonephritis (revised version of the World Health Organisation [WHO] class III, IV) | — |
Countries
Belgium, Denmark, Italy
Outcome results
None listed